(11 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional volumetric pump technology and its similarity to predicate devices from the 1990s.
Yes
The device is described as an "infusion system" intended for the "delivery of fluids, medications, blood and blood products" through "clinically acceptable routes of administration," which are therapeutic actions.
No
The device is an infusion system used to deliver fluids, medications, blood, and blood products, not to diagnose a condition.
No
The device description explicitly states it is an "electrical volumetric pump" and "administration sets," which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the delivery of fluids, medications, blood, and blood products into the body through various routes of administration. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of controlling the rate or monitoring the flow of solutions for delivery. It doesn't mention analyzing samples from the body to diagnose conditions.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition
The device is clearly an infusion system used for administering substances to a patient, which falls under the category of therapeutic or supportive medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Signature Edition Infusion System (infusion pumps and administration sets) is intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.
The Signature Edition Infusion System is indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
Product codes (comma separated list FDA assigned to the subject device)
FRN, FPA
Device Description
This device is essentially the same as the originally submitted devices (the predicate devices), filed as Models EZ 1 and EZ 2 Infusion Pumps (K931549) and EZ Administration Set Series (K931550). The electrical volumetric pumps and administration sets are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. In general, infusion systems are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid delivery, infusion systems have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional healthcare environment including healthcare facilities, home care, and medical transport
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
JUL 25 2003
SIGNATURE EDITION INFIJSION SY
ATTACHMENT D
SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems, Inc. Signature Edition Infusion System
| SUBMITTER'S NAME: | ALARIS Medical Systems, Inc.
10221 Wateridge Circle
San Diego, CA 92121-2772
(858) 458-7830
(858) 458-6114 FAX |
| ------------------- | ---------------------------------------------------------------------------------------------------------------------------- |
|---|
CONTACT PERSON: Stacy L. Lewis Regulatory Affairs Associate
July 10, 2003 DATE PREPARED:
DEVICE NAME: Proprietary Name Signature Edition Infusion System
Common Name Infusion Pump IV Administration Sets
Classification Name Pump. Infusion and accessories, FRN (880.5725) Administration Sets, Intravascular, FPA (880-5440)
DEVICE DESCRIPTION
This device is essentially the same as the originally submitted devices (the predicate devices), filed as Models EZ 1 and EZ 2 Infusion Pumps (K931549) and EZ Administration Set Series (K931550). The electrical volumetric pumps and administration sets are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. In general, infusion systems are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid
1
SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 2
delivery, infusion systems have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions. See Section 5 for a detailed device description and comparison.
SUBSTANTIAL EQUIVALENCE
The Signature Edition Infusion System is essentially the same as the predicate devices in that they have the same intended use, operating principles, technological design, incorporate similar materials and manufacturing processes. The changes as described in this Special 510(k) pose no new issues of safety or efficacy. The Signature Edition Infusion System as described in this submission is substantially equivalent to the predicate devices. See Section 6 for substantial equivalence details and a comparison table.
INTENDED USE
The intended use of this device has not changed from the original submissions in terms of content or intent. The Signature Edition Infusion System (infusion pumps and administration sets) is intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. A separate Indications for Use statement is provided in Attachment B.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Signature Edition Infusion System and the predicate devices has been performed. The results of this comparison demonstrate that the Signature Edition Infusion System is equivalent in technological characteristics and the fundamental scientific technology of the predicate devices has not been altered.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles a stylized human figure or a caduceus, with three curved lines representing the body and a wavy line at the bottom.
Public Health Service
JUL 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stacy L. Lewis Regulatory Affairs Associate Alaris Medical Systems Incorporated Worldwide Headquarters 10221 Wateridge Circle San Diego, California 92121-2772
Re: K032147
Trade/Device Name: Signature Edition Infusion Pump Regulation Number: 880.5275, 880. 5440 Regulation Name: Infusion Pump and Administration Set Regulatory Class: II Product Code: FRN, FPA Dated: July 10, 2003 Received: July 14, 2003
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, and Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
S.A. Winchester
for
Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment B
INDICATIONS FOR USE
510(k) Number: (To Be Assigned By FDA)
Device Trade Name: Signature Edition Infusion System
Indications For Use:
The Signature Edition Infusion System (infusion pumps and administration sets) is intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.
The Signature Edition Infusion System is indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE). The Concertion (Carro as the | |
|---|---|
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
5100 Number. K032147
Prescription Use __ U
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)